Following the MDIC’s EFS Site Best Practices workshop in March 2019, Martin Leon, MD (Columbia University Medical Center), Aaron Kaplan, MD (Dartmouth-Hitchcock, Serial Entrepreneur), Michael Mack, MD (Baylor), Chip Hance (Regatta Medical) and David R. Holmes, Jr., MD (Mayo Clinic), conceived a meeting focused on the issues of Early Feasibility Studies from the clinicians’ perspective. Specifically, the meeting focused on the following three areas:
●Identification of relevant patient population/Patient screening
●Patient consent
●Procedural and clinical follow-up issues
The program addressed these specific topics with different presentations followed by robust audience participation for discussion with clinical investigators and industry sponsors. This program took place on Wednesday, June 12, 7:00-9:30 pm, at the Sheraton Grand in Chicago.
This event was sponsored by MDIC in collaboration with CRF.
Panelists Include:
• Howard C. Herrmann, Penn Medicine
• Vinod Thourani, Medstar Heart and Vascular Institute
• Michael Mack, Baylor Scott & White
• Scott Lim, University of Virginia
• Bernard Vasseur, FDA
Event Materials:
Download workshop materials below. Note: File opens in web browser by default. Please save the file and open in a compatible PDF viewer to utilize navigation indexes.
Individual Event Materials:
- Symposium Agenda and Attendees
- EFS Symposium: Implementation Strategies for Early Feasibility Studies | David R. Holmes, Jr., MD, Mayo Clinic
- MDIC Introduction and Program Update, Pamela Goldberg | MDIC, Chip Hance | MDIC EFS Initiative Board Champion
- Topic # 1: Identification of relevant patient population/Patient screening, Scott M. Chadderdon, MD | OHSU | Blessie Concepcion | Boston Scientific
- Topic # 2: Patient consent, Charles J. Davidson, MD, FACC, FAHA, FSCAI | Northwestern Jill Trekell | Edwards Lifesciences
- Topic # 3: Procedural and clinical follow-up issues, Tamim Nazif, MD | Columbia, Chris Cain | Conformal Medical, Inc.
- Conclusions
Full Event PDF Packet:
EFS Symposium at TVT 2019 PDF Packet
